Sealing barrier arrangement

ABSTRACT

The present invention relates to a barrier membrane arrangement ( 10, 110 ) for a medical device for providing a substantially liquid tight seal between a piercing member and a barrier member ( 12 ) and a method for manufacturing such a barrier member arrangement. The present invention also relates to a method for connecting a first and a second medical device at the barrier member arrangement ( 10, 110 ). The barrier member arrangement ( 10, 110 ) comprises a first member ( 11 ), a second member ( 13 ) and a barrier member ( 12 ). The second member ( 13 ) can be interlocked to the first member ( 11 ) by means of a connection arrangement ( 18 ) at an optional stage by a user. After interlocking the second member ( 13 ) to the first member ( 11 ), the barrier member ( 12 ) has been compressed to provide for an increased leakage security. The barrier member arrangement ( 10, 110 ) also provides for a prolonged working life of the barrier member ( 12 ) and any medical device which comprises such a barrier member arrangement ( 10, 110 ).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/318,897, filed Apr. 20, 2012, now U.S. Pat. No. 9,493,281, which is anational stage entry of PCT/EP2009/055354, filed on May 4, 2009, whichis incorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention relates to a barrier member arrangement for amedical device, a medical device having at least one such barrier memberarrangement, a method for manufacturing such a barrier memberarrangement and a method for connecting a first and a second medicaldevice at the barrier arrangement. The barrier member arrangementenables an improved working life of the barrier member.

BACKGROUND OF THE INVENTION

A serious problem in connection with drug preparation, drugadministration or other similar handling, is the risk that medical andpharmacological staff are exposed to drugs or solvents which mightescape into the ambient air. This problem is particularly serious whencytotoxins, antiviral drugs, antibiotics and radiopharmaceuticals areconcerned. Other hazardous areas may be sampling taking such as samplesrelating to virus infections or the like. For these reasons, there hasbeen a need of safer systems for handling and administrating drugs andother medical substances.

Accordingly, U.S. Pat. No. 4,564,054 (Gustaysson) discloses a fluidtransfer device for transferring a substance from one vessel to anothervessel while avoiding leakage of liquid and gas contaminants. Thedisclosed device comprises a first member designed as a hollow sleeveand having a piercing member provided with a passageway. The piercingmember is attached to the first member which has a first barrier memberat one end just opposite the tip of the piercing member. Thereby, thepiercing member can be passed and retracted through the first barriermember which seals one end of the first member. The fluid transferdevice further comprises a second member which is attached to orattachable to one of the vessels or to means arranged to communicatetherewith. The second member has a second barrier member, and matingconnection means arranged on the first and second members for providinga releasable locking of the members with respect to each other. In theconnected position of the first and second members, the barrier membersare located in such a way with respect to each other that the piercingmember can be passed therethrough.

The barrier members are liquid and gas-proof sealing members sealingtightly after penetration and retraction of the piercing member toprevent leakage of liquid as well as gas contaminants. Another exampleusing a barrier member is the U.S. Pat. No. 3,900,028 in which aninjection site for a liquid bottle having a first cylindrical memberinterposed of a second cylindrical member and a barrier member arrangedtherebetween is disclosed. During manufacturing of the injection site,the second member is telescopically inserted into an opening at a lowerend of the first member. The barrier member is tightly compressed in thelongitudinal direction of the first and second members. The firstcylindrical member is thereafter fixed to the second cylindrical memberby means of a rib on the first cylindrical member and a groove on thesecond cylindrical member. The rib of the first cylindrical member isformed by deforming the lower edge of the first cylindrical member bysubjecting it to heat and pressure during the manufacturing of theinjection site.

Barrier members used in the above mentioned applications are usuallymade from a natural or synthetic rubber or a rubber like material.However, it has been found that medical devices such as those mentionedabove suffer from a limited working life. For example, by compressingthe barrier member during manufacturing too much, the barrier membranecan be damaged, likewise, by compressing the barrier membrane toolittle, the medical device can leak. It has further been realized thatthe compression itself can cause a reduced working life for the medicaldevices.

SUMMARY OF THE INVENTION

It is an object of the present invention to solve or at least partlyreduce the above mentioned drawbacks. More specifically they are atleast partly reduced by a barrier member arrangement for a medicaldevice for providing a substantially liquid tight seal between apiercing member and a barrier member. The barrier member arrangement hasa centre axis and comprises a first member, a second member and abarrier member. At least the first member comprises a through aperturethrough which the piercing member is intended to extend afterpenetrating the barrier member. The barrier member is further arrangedto cover the through aperture of the first member. The first and/or thesecond member(s) further comprise a connection arrangement to interlockthe first and the second members to each other at an interlockedposition. Furthermore, at least the second member is operable at anoptional stage by a user between at least a first position, in which thebarrier member is subjected to zero, or a first compression force, andthe interlocked position, in which the barrier member is subjected to asecond compression force and wherein the second compression force islarger than the zero or the first compression force.

The present invention provides for a barrier member arrangement whichprolongs the working life of the barrier member as the barrier memberdoes not need to be compressed during manufacturing of the barriermembrane arrangement but can be compressed immediately prior to use orwhen a user so desires. This saves the barrier member from beingcompressed during transportation and storage. Medical devices cansometimes be stored for several years before use, thus by relieving thebarrier member from compression during such a long storage time theworking life of the barrier member can be significantly prolonged. Forexample, the barrier member can be compressed when a user, such as anurse, care taker or doctor, is about to administrate drugs into aninfusion bag using an injector comprising a barrier member arrangementaccording to the present invention. Just before connecting the injectorto the infusion bag, the user compresses the barrier member to improvethe barrier member's sealing properties and thereby reduce the risk forleakage of drugs during administration.

The improved sealing properties can further be utilized for differentpurposes. The compression can be increased around the periphery of thebarrier member providing a substantially circumferential compressionforce around the barrier member, to improve the barrier member's sealingproperties in that area, and/or the compression can be directed towardsthe centre axis to improve the sealing properties of the barrier memberin that area, which would be advantageous for reducing the risk ofleakage along a piercing member. Combinations of the above are desirableand possible.

The second member may be connected in a wide variety of ways to thefirst member, the second member can be pivotally connected to the firstmember, for example, as an integrated piece or as a separate piece. Thisis advantageous since it enables a simple and precise interlocking ofthe second member to the first member. The pivot connection can be saidto guide the second member to the interlocked position.

In an embodiment according to the present invention, the second memberis adapted to compress the barrier member directly or indirectly so thatthe compression force is achieved. This can be achieved for example byat least one compression surface arranged on the second member. Thecompression surface can be arranged to compress the barrier member alongthe centre axis X, or towards the centre axis X, or a combinationthereof. The compression surface can be a tilting surface extendingaround the periphery of the through aperture of the second member, forexample. In this case, the at least one tilting surface exerts thecompression force on the barrier member after the second member has beeninterlocked with the first member. The tilting surface can be tiltedwith an angle α of between 25-65 degrees with respect to a plane P thatis parallel with the upper surface of the barrier member, as indicatedin FIG. 1 defined by the Y and the Z axis. The angle α should further berelated to when the second member is connected to the first member, i.e.when the second member is substantially parallel with the plane P, asshown in FIG. 2b . Optionally, a similar tilting surface can be arrangedon the first member, or both the first and the second member.

The barrier member is advantageously compressed so that the impartedcompression force provides for an increased retraction force of aninserted piercing member, with respect to the required retraction forcefor the same inserted piercing member before the first and secondmembers are connected. The method for evaluating this is outlined below.It is believed that the increased compression force provides for abetter sealing around the piercing member, and thereby reduces the riskof leakage. However, it has also been found that the compression forceshould not be too large, as it could make it difficult for a user toeasily and safely retract the inserted piercing member from the barriermember. The increase in the required retraction force should be in theorder of 5-100%, preferably 5-50%, more preferably 10-50%.

The barrier member arrangement can be provided with different means forproviding the interlocking between the first and the second member. Inan embodiment according to the present invention, the connectionarrangement can be a snap-on connection arrangement, extendingsubstantially around the whole periphery of the second member or bearranged at individual locations. The snap-on connection arrangement cancomprise at least one hook member which is arranged to be in workingcooperation with at least one groove or optionally at least oneprotrusion. In an embodiment according to the present invention, therecan be a plurality of cooperative grooves or protrusions for the atleast one hook member(s), arranged along the centre axis X as shown ine.g. FIG. 4. The cooperative grooves or protrusions enable a variationof the imparted compression force, although a maximum compression forcecan be provided as the second member will eventually be stopped whenpositioned adjacent the first member. The connection arrangement canfurther optionally be a threaded connection arrangement. Combinations ofthe above connection arrangements are also possible, the second membercan be arranged to firstly snap-on and then to be turned so as tocompress the barrier member with a suitable compression force, forexample.

The barrier member can be attached to the first member in a variety ofdifferent ways or optionally it can simply be placed on the first memberand not bonded to the first member at all. It should be noted that whenthe second member is interlocked with the first member and the barriermember is compressed, the barrier member can be effectively sealedaround its periphery. The barrier member can however be chemicallybonded, e.g. by form molding the barrier member directly onto the firstmember, adhered, or mechanically attached to the first member. Thesedifferent manufacturing steps have similar and specific advantages.

In an embodiment according to the present invention, the second membercomprises connection means for connecting to a second medical device.The connection can be a neck element having at least one guiding groove,preferably two guiding groves, for example. Optionally the connectionmeans can be at least one protrusion, preferably two protrusions,adapted to cooperate with at least one, preferably two guiding grooves.

The present invention also relates to a medical device comprising atleast one barrier member arrangement as described herein in all itsdifferent aspects and variations. The medical device can comprise two,three, four or more barrier arrangements according to the presentinvention. The medical device can be selected from the group of;injectors, infusion bags or containers, drug administration systems,fluid transfer adaptors, vials, catheters, injection sites, piercingmember protection devices or the like.

Hence, the present invention relates to a barrier membrane arrangementfor a medical device for providing a substantially fluid tight seal,i.e. liquid and/or gas tight seal, between a piercing member and abarrier member. The present invention also relates to a medical devicehaving at least one barrier member arrangement and a method forconnecting a first and a second medical device at the barrier memberarrangement. The barrier member arrangement comprises a first member, asecond member and a barrier member. The second member can be interlockedto the first member by means of a connection arrangement by a user.After interlocking the second member to the first member, the barriermember is arranged to be compressed to provide for an improved leakagesecurity. The barrier member arrangement provides for a prolongedworking life of the barrier member and any medical device whichcomprises such a barrier member arrangement.

The present invention also relates to a method for manufacturing abarrier member arrangement, especially as described above in any of itsdifferent embodiments. The method comprises the steps of; form moldingthe first and second members as one integrated piece whereby the secondmember is movable between a first position and an interlocked position.In the interlocked position, the second member is interlocked to thefirst member. The method also comprises the step of providing a barriermember on the first or the second member when the second member is inthe first position and in a subsequent step;

interlocking the first and second members so as to subject the barriermember to a compression force. The present invention provides for abarrier member arrangement which effectively simplifies themanufacturing of the barrier arrangement as the barrier member can beform molded directly onto the first or the second member without riskingan ill fitting barrier member due to the complexity of attaching abarrier member while subjecting the barrier member with a compressionforce. Instead, the barrier member is compressed as a separate step wheninterlocking the second member to the first member.

The second member can be form molded so as to be pivotally connected tothe first member which is very advantageous. The interlocking of thefirst and the second members can in such a case be made by a pivotmotion. The barrier member can be form molded on the first or the secondmembers subsequently after, the first and second members have been formmolded. Optionally it can be form molded substantially simultaneously.

It should be noted that by applying a compression force to a barriermember, the barrier member itself does not need to be compressed, it maybe that parts of the barrier member is simply displaced by the exertedcompression force. Hence the terminology that the barrier member iscompressed used herein and hereafter is to be understood as the barriermember can compressed and/or that parts of the barrier member is atleast partly displaced.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be described in greater detail with referenceto the accompanying figures in which;

FIG. 1 shows a view in perspective of a barrier member arrangementaccording to an embodiment of the present invention;

FIG. 2a shows a cross section of the barrier member arrangement as shownin FIG. 1 before the second member is interlocked with the first member;

FIG. 2b shows a cross section of the barrier member arrangement as shownin FIG. 1 after the second member is interlocked with the first member;

FIG. 3 shows the barrier member of the embodiment shown in FIG. 2abefore compression;

FIGS. 4 and 5 shows barrier membrane arrangements according toadditional embodiment of the present invention having differentconnection arrangements for interlocking the first and the secondmember;

FIGS. 6a and 6b shows a cross section of the barrier arrangementaccording to an embodiment of the present invention in the form of avial adapter;

FIGS. 7-8 shows a medical device having a barrier member arrangementaccording to one embodiment of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 shows a barrier member arrangement 10 for a medical deviceaccording to one embodiment of the present invention. The barrier memberarrangement 10 can be fitted on a vial, infusion bag, catheter or anyother suitable medical device which needs a barrier member for providinga substantially liquid tight sealing around a piercing member duringfluid transfer. The barrier member arrangement has a centre axis X,which in principal defines the intended path for the piercing member,illustrated in FIG. 1 as a vertical double headed arrow. A horizontal Xand Y axis form a vertical plane P at any given point along the centreaxis X.

The barrier member arrangement 10 comprises a first member 11, which isarranged to hold a barrier member 12 in a substantially non compressedconfiguration. The first member 11 comprises a substantially cylindricalform having a longitudinal extension along the centre axis X and acircumferential extension in the vertical plane P. A second member 13 ispivotally connected to the first member 11 at a pivot axis 14 whichenables the second member 13 to be closed around, and partly over, thebarrier member 13 like a lid during assembly. The first member 11comprises a through aperture 15, indicated with reference number 15 inFIGS. 2a-2b , 5 and 6. The second member 13 comprises a through aperture19 through which parts of the barrier member can extend after assembly,when the barrier member 12 is configured as shown in e.g. FIG. 1. Itshould be noted that the second member does not necessarily need thethrough aperture 19, instead an open aperture can be used. Optionally aplurality of pivotally connected second members can be used to compressthe barrier member.

A connection arrangement comprising a hook like projection 16, i.e. ahook member, on the second member 13, and a cooperating projection 17 onthe first member 11 form a connection arrangement 18 to enable fixationof the second member 13 to the first member 11.

When the second member 13 is fixedly connected to the first member 12 bymeans of the connection arrangement 18, the second member 13 at leastpartly compresses the barrier member 12 with a compression forcedirected towards the centre axis X. A user, piercing the barrier member12 with a piercing member, such as a needle, will notice that thebarrier member is harder to pierce with the piercing member after thesecond member 13 has been fixed to the first member 11, as compared tobefore interlocking the second member 13 to the first member 11.

FIGS. 2a-2b shows a cross section of the barrier arrangement 10 fromFIG. 1 before and after moving the second member 13 to thereby compressthe barrier member 12. More specifically, FIG. 2a shows the first member11 having a first and a second end 21, 22 and a fluid transfer channel23, for transporting a fluid, extending therebetween. It should be notedthat the second end 22 of the first member 11 can be arranged onsubstantially any kind of medical device. The fluid transport channel 23comprises a first and a second opening 24, 25. The pivot axis 14pivotally connects the second member 13 to the first member 11, enablingthe second member 13 to be closed over the barrier member 12 andconnected to the first member 11 via the connection arrangement 18, asseen in FIG. 2b . The first member 11 comprises an inner and an outersurface 27, 28, the inner surface 27 defines the fluid transport channel23. The first and the second members 11, 13, referred to throughout thedescription, can be formed by separate components but are advantageouslyformed as one integrated piece of material.

The barrier member 12 is arranged to cover the first opening 24 of thefirst member 11 and can be adapted to provide a fluid tight seal betweenthe first member 11 and the barrier member 12 along a circumferentialflange 26 extending around the inner surface 27 and towards the centreaxis X. Optionally, a liquid tight seal between the barrier member 12and the first member 11 can be provided when interlocking the first andthe second members 11, 13 by means of the connection arrangement 18.

The second member 13 comprises a substantially circle formed lid-likemember having a first diameter D1. An opening 30 having a seconddiameter D2 extends through the second member 13 to receive parts of thebarrier member 12 after closure, as will be described below. The opening30 of the second member 12 exhibits a substantially circular form and isdefined by a circumferential surface 31 of the second member 13. Thecircumferential surface 31 tilts with and angle α respect to the centreaxis X and after the second member 13 is connected to the first member11, as seen in FIG. 2b . The circumferential tilting surface 31 impartsa compression force to the barrier member 12 as the second member 13 isconnected to the first member 11. More specifically, the circumferentialsurface 31 exerts compression mainly along a vector V, which can beresolved in two main directions; a first direction along the centre axisX towards the first member 11; and a second direction towards the centreaxis X parallel with the vertical plane P, the first and the seconddirections being indicated with dotted arrows in FIG. 2 b.

As the second member 13 is interlocked with the first member 11, thebarrier member 12 is compressed in a direction towards the centre axisX, as illustrated by the vectors V in FIG. 2b . The increasedcompression of the barrier member 12 will effectively provide for animproved seal around a piercing member, as is shown in FIG. 3.

FIG. 3 shows the barrier member 12 in greater detail after beingpenetrated by a piercing member, in this case part of a needle 40 havinga tip 41. The barrier member 12 comprises a first and a second section50, 51. The first section 50 of the barrier member 12 is intended toextend through the opening 30 of the second member 13 after beinginterlocked with the first member 11, while the second section 51 isintended to brace against the second member 13 and especially thecircumferential surface 31, as explained above. The second section 51thus exhibits a larger diameter than the second diameter D2 of thesecond member 13 but a smaller diameter than the first diameter D1 ofthe second member 13. The first section 50 of the barrier member 12exhibits a smaller diameter as compared with the second diameter D2 ofthe second member 13 to enable the first part 50 of the barrier member12 to extend through the opening 30 after connection with the secondmember 13. Both the first and the second sections 50, 51 of the barriermember 12 comprise a circular form and a height H1 and H2 respectively.

As the barrier member 12 comprises a first and a second section 50, 51it is notable that the first section 50 is left uncompressed in thesense that it is not directly imparted by the second member 13. Hence,in an embodiment according to the present invention, the barrier membercomprises a compressed section and a substantially uncompressed section.

As is illustrated in FIGS. 2a-2b , the second member 13 is pivotallyconnected to the first member 11 and provided with a connectionarrangement 18 for connecting the second member 13 to the first member11, so as to impart a compression force on the barrier member 12. FIG.4-6 shows different arrangements for connecting the second member 13 tothe first member 11 so as to impart a compression force on the barriermember 12.

More specifically, FIG. 4 shows an embodiment according to the presentinvention in which the first member 11 comprises a snap-on arrangement.The snap-on arrangement comprises at least one protrusion 71 extendingaround at least parts of the periphery of the outer surface 28 at thefirst end 21 of the first member 11. The second member 13 comprises acorresponding snap-on flange 72, arranged around the periphery of thesecond member 13, enabling the second member 13 to be fitted onto thefirst member 11 imparting a compression force to the barrier member 12.

FIG. 5 shows an embodiment according to the present invention in whichthe first member 11 comprises threads 81 extending around the peripheryof the outer surface 28 in the proximity of the first end 21 of thefirst member 11. The second member 13 comprises corresponding threads 82enabling the second member 13 to be fitted by means of rotation, asindicated by the arrow in FIG. 5, onto the first member imparting acompression force to the barrier member 12. As the second member 13 willbe unable to turn as the first end 21 of the first member 11 will stopthe second member 13, there will be a maximum of the impartedcompression force to the barrier member. Hence the second member 13 isattached to the first member 11 so that a designated compression forceis exerted to the barrier member 12, while before attachment; thebarrier member 12 is uncompressed.

Generally for embodiments according to the present invention, the secondmember 13 can be either clearly separated from the first member 11before attachment, or be preassembled with the first member 11, as shownin FIG. 2a for example. Furthermore, the first and the second member 11,13 can be integrated or manufactured from separate pieces and thereafterassembled. If the first and the second members 11, 13 are integratedthey can be form molded in one piece for example.

FIGS. 6a and 6b shows a cross section of a barrier arrangement 10,according to the present invention, in the form of a vial adapter. Thevial adapter comprises a first member 11 adapted to be secured to a vialby means of a plurality of flexible tongue-like elements 61, 62, howeveronly two tongue-like elements are shown in FIG. 6a, 6b . The number oftongue-like elements can be in the range of 2-10, preferably 4-8. Eachtongue-like element 61, 62 comprises a hook-like protrusion 63, eachhook-like protrusion 63 comprises a tilting surface and a lock surface64, 65 cooperative with the vial for attaching the vial adaptor. Theplurality of flexible tongue-like elements 61, 62 are displacedoutwards, away from the centre axis X as the vial adaptor is slided overthe vial for attachment. When the hook-like protrusions 63 of theplurality of flexible tongue-like elements 61, 62 passes the cooperativesurface of the vial for attachment, the plurality of flexibletongue-like elements 61, 62 returns to their substantially originalposition to thereby fix the vial adaptor to the vial, as is shown inFIGS. 6a and 6 b.

The plurality of flexible tongue-like elements 61, 62 of the firstmember 11 extends from a substantially circular base 66 which afterassembly with the vial is adapted to be positioned adjacent or in theproximity of the vial opening.

The first member 11 is further provided with a snap-on arrangement for asecond member 13. The snap-on arrangement comprises a plurality ofprotrusions 71 extending around at least parts of the periphery of theouter surface 28 of the first member 11 and the plurality of flexibletongue-like elements 61, 62.

The second member 13 exhibit a circular base wall 73, having a circularwall 74 extending in a perpendicular direction therefrom around theperiphery of the circular base wall 73. The circular wall 74 comprisesan inner surface 75 facing the centre axis X. Snap-on flanges 72corresponding to the snap-on protrusions 71 are arranged on the innersurface 75 of the circular wall 74 of the second member 13, enabling thesecond member 13 to be fixedly fitted onto the first member 11, as shownin FIG. 6a . As the second member 13 is moved along the centre axis Xtowards the first member 11, i.e. to the position as shown in FIG. 6b ,a compression force is imparted to the barrier member 12.

In the shown embodiment of the present invention, the barrier member 12is arranged on the first member 11, covering a through aperture 15arranged at the centre of the first member 11. A through aperture 76 isarranged on the second member 13 in a similar way, to at least partlycover the barrier member 12 after being interlocked with the firstmember 11, as shown in FIG. 6 b.

The second member 13 further comprises connection means for attaching asecond medical device. The connection means for attaching a secondmedical device are the same as described with reference to FIG. 7, i.e.having a neck element comprising two guiding members to which a secondmedical device can be connected. Such a second medical device can be aninjector e.g. as described in the patent publication of WO 2004/004806,for example.

One of the advantages with the embodiment shown in FIG. 6a, 6b is that auser can impart a compression force to the barrier member 12 immediatelyprior to use, while substantially simultaneously preventing theplurality of flexible tongue-like elements 61, 62 from being releasedfrom the vial. Hence, in one embodiment according to the presentinvention, the barrier member arrangement 10 is arranged to preventdisengagement of a medical device while substantially simultaneouslyimpart a compression force to the barrier member by interlocking thefirst and the second member, directly or indirectly together.

FIG. 7 shows a medical device in the form of a fluid transfer device 100comprising a barrier arrangement 110 according to an embodiment of thepresent invention.

The fluid transfer device 100 comprises a first and a second member 111,113 and a barrier member 112 therebetween. The fluid transfer device 100is shown in FIG. 7 in its connected state at which the second member 113has been connected to the first member 111 so that the barrier member isin a compressed state, being compressed with a designated compressionforce.

As can be seen, the second member 113 comprises a connection means 118having a neck element 151 comprising two guiding members 152, 153 towhich a second medical device can be connected. Such a second medicaldevice can be an injector e.g. as described in the patent publication ofWO 2004/004806, for example. The first member 111 also comprises meansfor being connected to a medical device, in this case a differentmedical device. The barrier member 112 can be seen through the neckelement of the connection means 150.

FIG. 8 is a cross section of the embodiment shown in FIG. 7 shown beforethe second member 113 has been connected to the first member 111 so asto compress the barrier member 112. As can be seen in FIG. 8, the firstmember 111 comprises a rotable nut 120 having threads 121 arranged onits inner surface 122 and which is rotably arranged to the first member111. The rotable nut 120 forms part of a connection means for a medicaldevice to the first member 111, in this case the connection means is amodification of a luer-lock connection.

A first locking means 130, prevents the rotable nut 120 from turning ina predetermined direction, which can be either clock-wise or anticlock-wise with respect to the first member 111, while permitting it toturn in the opposite direction of the predetermined direction. The firstlocking means 130 may comprise a plurality of saw tooth protrusionsarranged on the second member 113, for example.

The second member 113 is further pivotally connected at a pivot axis114. The pivot axis 114 can be made form a separate axle, such as ametal pin, or be integrally formed with the first and the second member111, 113, just as in the shown embodiment in FIG. 2 a.

The present invention also relates to a method for connecting a firstand a second medical device. The method comprises the steps of providinga first medical device comprising a barrier member arrangement,compressing the barrier member from a first substantially uncompressedstate, to a second designated compressed state, and thereafterconnecting the second medical device to the first medical device.

Without being bound by theory, it is believed that by postponing thecompression of the barrier member the working life of the barrier membercan be prolonged. Other advantages can be that the barrier member isless subjective to other disruptive parameters while it is kept in itsuncompressed state.

The barrier member 12 can be made of a suitable polymeric material suchas a silicone based rubber, natural rubber, or the like.

It should be noted that the second member need not necessarily bearranged to compress the barrier member directly, but it can be arrangedto cause one or more intermediate components to directly compress ordisplace the barrier member. Furthermore, the barrier member may bearranged to be compressed or displaced radially inwards in a directionopposite to the direction in which a piercing member is to penetratetherethrough, or in any other number of ways substantiallysimultaneously.

The invention claimed is:
 1. A barrier member arrangement comprising: acentre axis; a first member having a one or more flexible tongue-likeelement to be secured to a vial; a second member having a circular basewall, a circular wall extending in a perpendicular direction around aperiphery of the circular base wall; wherein the circular wall comprisesan inner surface facing the centre axis having one or more snap-onflanges corresponding to one or more snap-on protrusions are arranged onthe inner surface of the circular wall of the second member; and abarrier member arranged on the first member to cover a through aperturearranged at a centre of the first member through which a piercing memberextends after penetrating the barrier member, the first member isarranged to hold the barrier member in a non-compressed configuration.2. The barrier member arrangement of claim 1, wherein the one or moreflexible tongue-like element comprises a hook-like protrusion.
 3. Thebarrier member arrangement of claim 2, wherein the hook-like protrusioncomprises a tilting surface and a lock surface cooperative with thevial.
 4. The barrier member arrangement of claim 1, wherein the firstmember further comprises a snap-on arrangement for the second member. 5.The barrier member arrangement of claim 4, wherein the snap-onarrangement comprises a plurality of protrusions extending around aperiphery of an outer surface of the first member and the one or moreflexible tongue-like elements.
 6. The barrier member arrangement ofclaim 1, wherein the second member further comprises a neck elementhaving two guiding members for connecting a second medical device. 7.The barrier member arrangement of claim 1, wherein the barrier member ismade of a polymeric material.
 8. The barrier member arrangement of claim7, wherein the polymeric material is a silicone rubber.
 9. The barriermember arrangement of claim 1, wherein the first member furthercomprises a rotable nut having threads arranged on an inner surface ofthe first member.
 10. The barrier member arrangement of claim 9, furthercomprising a first locking means that prevents the rotable nut 120 fromturning in a predetermined direction while permitting it to turn in anopposite direction of the predetermined direction.
 11. The barriermember arrangement of claim 10, wherein the first locking meanscomprises a plurality of saw tooth protrusions arranged on the secondmember.
 12. The barrier member arrangement of claim 11, wherein thesecond member is pivotally connected at a pivot axis.
 13. The barriermember arrangement of claim 12, wherein the pivot axis is a separateaxle.
 14. The barrier member arrangement of claim 12, wherein the pivotaxis is integrally formed with the first member and the second member.15. A medical device comprising a barrier member arrangement of claim 1.16. The medical device of claim 15, wherein the medical device isselected from the group consisting of: an injector, an infusion bag, adrug administration system, a fluid transfer adaptor, a vial, acatheter, an injection site, a piercing member protection device or avial adapter.
 17. A method for manufacturing a barrier memberarrangement of claim 1, wherein the method comprising the steps of: formmolding the first and second members as one integrated piece and wherebythe second member is movable between a first position and an interlockedposition, in which the second member is interlocked with the firstmember, providing a barrier member on the first or the second memberwhen the second member in the first position and in a subsequent step,interlocking the first and second members so as to subject the barriermember with a compression force.
 18. The method of claim 17, wherein thesecond member is form molded so as to be pivotally connected to thefirst member.
 19. The method of claim 17, wherein the barrier member isform molded to the first member or the second members immediately afterthe first member and second members have been form molded.
 20. A methodfor connecting a first and a second medical device, the methodcomprising the steps of, providing a first medical device comprising abarrier member arrangement of claim 1, compressing the barrier memberfrom a zero compressed state or from a first compressed state, to asecond compressed state, whereby the second compressed state is greaterthan zero or the first compressed state respectively and, afterconnecting a second medical device to the first medical device.